technologies-optional :

responsibilities :

Based on your expertise in Computer System Validation, you ensure that changes are managed according to our validation rules in close collaboration with local experts of our GBS user community.
Acting as a Validation Specialist, you support our daily operation of processes and applications.
This ensure that our processes and systems are always compliant and in a validated state.
Furthermore, you manage the execution and documentation of testing activities.
You are familiar with agile methods and tools, participating to projects driven by this methodology.
You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs) in order to strive for continuous improvement measures.

requirements-expected :

You should speak English fluently and have experience in Validation Management, ideally in Computer Systems Validation (CSV).
Additionally, we are looking for:
Bachelor’s Degree; preferably in Business Administration, Finance & Controlling, Engineering, Sciences, Pharmaceuticals or Biotechnology or equivalent and longstanding professional experience in regulations and processes.
Good knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation would be an advantage.
Good Knowledge of GxP (Good Practices) regulations within the Pharmaceutical Industry.
Experience with agile methods (e.g., SCRUM, Kanban) and tools (e.g., JIRA, SAP Solution Manager) would be an advantage.
Good analytical capabilities and problem-solving competence including a proper understanding of prioritization.
Dedicated team player with good communication skills, and a structured way of working.

benefits :

responsibilities :